A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Recruiting
Phase 2Interventional Study
Atopic DermatitisEczema, Atopic
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
165 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 64 with moderate to severe eczema who have not found a suitable treatment. Participants will take either the study medicine PF-08049820 or a placebo for 12 weeks and visit the clinic several times to check their health and skin condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 to 64 years old
I have been diagnosed with eczema for at least 6 months
I have moderate to severe eczema
I do not have a suitable prescribed medicine for eczema
I have a body weight greater than 48 kg
You may not be able to join if
I have an infection that requires treatment
I have other skin conditions besides eczema
I have severe uncontrolled asthma
I have used a tanning booth or phototherapy for eczema more than twice a week in the last 4 weeks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.
The study is seeking participants who:
1. Are 18 to 64 years of age;
2. Were confirmed to have AD at least 6 months ago;
3. Do not have a suit…
The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.
The study is seeking participants who:
1. Are 18 to 64 years of age;
2. Were confirmed to have AD at least 6 months ago;
3. Do not have a suitable prescribed medicine for AD;
4. Are considered by their doctors to have moderate to severe AD.
The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.
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Eligibility Criteria
Inclusion Criteria:
Participants must meet the following criteria:
1. Are 18 to 64 years of age
2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
3. Have moderate to severe AD as defined by the following at screening and baselin…
Inclusion Criteria:
Participants must meet the following criteria:
1. Are 18 to 64 years of age
2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
3. Have moderate to severe AD as defined by the following at screening and baseline visits:
* Affected body surface area (BSA) greater than or equal to 10% and up to 60%;
* Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;
* Eczema Area and Severity Index (EASI) greater than or equal to 16;
AND
-Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit
4. Do not have a suitable prescribed medicine for AD.
5. Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs)
Exclusion Criteria:
Participants must not meet the following criteria:
1. Have an infection that requires treatment
2. Have other skin conditions other than AD
3. Have severe uncontrolled asthma
4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit
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